Stability of the Powdered Dosage Form Prepared by Unsealing the Capsules: Water Vapor Sorption and Discoloration of the Powdery Contents of Clorazepate Dipotassium Capsules

Takehisa Hanawa Department of Pharmacy, Yamanashi Medical University, 1110, Tamaho, Nakakoma-gun, Yamanashi, 409-3898, Japan

Tomohiro Ohta Pharmaceutical Department, Tokyo Women's Medical University, 8-1, Kawada-cho, Shinjuku, Tokyo, 162-8666, Japan

Fumiko Kimura Nicolet Japan Company, Limited, Moriya, Kanagawa-ku, Yokohama, Kanagawa, 221-0022, Japan

Takanori Tsuchiya Pharmaceutical Department, Tokyo Women's Medical University, 8-1, Kawada-cho, Shinjuku, Tokyo, 162-8666, Japan

Rieko Ikoma Pharmaceutical Department, Tokyo Women's Medical University, 8-1, Kawada-cho, Shinjuku, Tokyo, 162-8666, Japan

Tomomi Uchida Pharmaceutical Department, Tokyo Women's Medical University, 8-1, Kawada-cho, Shinjuku, Tokyo, 162-8666, Japan

Masahiko Suzuki Department of Pharmacy, Yamanashi Medical University, 1110, Tamaho, Nakakoma-gun, Yamanashi, 409-3898, Japan

Shin'ichiro Nakajima Department of Pharmacy, Yamanashi Medical University, 1110, Tamaho, Nakakoma-gun, Yamanashi, 409-3898, Japan

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Abstract

The hygroscopicity of the contents of clorazepate dipotassium (Mendon®) capsules (CM) was investigated by storage at various relative humidities (RHs). The CM adsorbed water vapor significantly at more than 75% RH. At the same time, a marked discoloration of CM from white to yellow was also observed during storage. On the basis of differential scanning calorimetry (DSC) and Fourier transform (FT) Raman spectroscopy, the discoloration seemed to be due to the change in clorazepate dipotassium to nordiazepam and other substances. It was found that, when opening of the Mendon capsule is necessary to prepare the powdered dosage form, the CM should be stored below 60% RH to avoid the adsorption of water vapor and discoloration.

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Stability of the Powdered Dosage Form Prepared by Unsealing the Capsules: Water Vapor Sorption and Discoloration of the Powdery Contents of Clorazepate Dipotassium Capsules

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Stability of the Powdered Dosage Form Prepared by Unsealing the Capsules: Water Vapor Sorption and Discoloration of the Powdery Contents of Clorazepate Dipotassium Capsules

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